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Health Care Law

CMS revises process and forms for reporting Stark Law violations

The Centers for Medicare and Medicaid Services (CMS) has issued new Self-Referral Disclosure Protocol (SRDP) forms that, beginning June 1, 2017, will be mandatory for most parties submitting voluntary self-disclosures of potential or actual violations of the federal physician self-referral law (Stark Law). The SRDP was established by the Patient Protection and Affordable Care Act as a way to give providers an opportunity to resolve Stark Law violations with CMS. CMS has revised the SRDP forms in an attempt to streamline the self-disclosure process.

The initial SRDP required disclosing parties to draft a detailed narrative description of the non-compliance that resulted in a Stark Law violation. However, these narrative descriptions resulted in inconsistent formats across disclosures and frequently required supplemental submissions to complete a disclosure. Under the revised SRDP, providers must now complete and submit the following:

The Physician Information Form, which requires information about each physician involved in the noncompliance that gave rise to the disclosure.

A Financial Analysis Worksheet, which requires the disclosing party to provide the financial analysis that quantifies the overpayment associated with the Stark Law violation.

A certification signed by the disclosing party of the truthfulness of the information contained in the disclosure.

Additionally, the SRDP forms now require the disclosing party to provide an estimate of the pervasiveness of Stark Law noncompliance as compared to similar relationships between the disclosing party and physicians. The forms also include instructions, examples and other information to assist the disclosing party in preparing a self-disclosure. The new forms will be required for all disclosures, except those by physician-owned hospitals reporting noncompliance with required website and advertising requirements, which must be reported using special instructions.

CMS hopes that the new forms will reduce the burden on disclosing parties and standardize the format for the presentation of the required information. Since its creation, the SRDP has assisted providers in resolving potential liability under the Stark Law. By the end of 2016, CMS had received 882 disclosures under the SRDP and settled 233 of those disclosures. Individual settlements during that time ranged from $60 to $1,195,763, and, so far, a total of $23,209,222 has been collected.